Brand Name | OCUSCAN RXP |
Type of Device | ULTRASONIC PULSED ECHO IMAGING SYSTEM |
Manufacturer (Section D) |
ALCON - IRVINE TECHNOLOGY CENTER |
15800 alton pkwy. |
irvine CA 92618 |
|
Manufacturer (Section G) |
ALCON - IRVINE TECHNOLOGY CENTER |
15800 alton pkwy. |
|
irvine CA 92618 |
|
Manufacturer Contact |
janet
moran
|
6201 south freeway |
r3-48 |
fort worth, TX 76134
|
8146152742
|
|
MDR Report Key | 3891733 |
MDR Text Key | 15126888 |
Report Number | 2028159-2014-01080 |
Device Sequence Number | 1 |
Product Code |
IYO
|
Combination Product (y/n) | N |
PMA/PMN Number | K842757 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Type of Report
| Initial |
Report Date |
05/14/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 8065741076 |
Device Catalogue Number | 8065741076 |
Other Device ID Number | 1.15 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
05/14/2014 |
Initial Date FDA Received | 06/10/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/01/2011 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|